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Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.","id":"EG001","otherNumAffected":216,"otherNumAtRisk":220,"seriousNumAffected":112,"seriousNumAtRisk":220,"title":"Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1"},{"description":"Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.","id":"EG002","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"Arm I (Lenalidomide, Dexamethasone) Step 2"},{"description":"Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.","id":"EG003","otherNumAffected":14,"otherNumAtRisk":14,"seriousNumAffected":3,"seriousNumAtRisk":14,"title":"Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2"},{"description":"Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.","id":"EG004","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)"},{"description":"Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.","id":"EG005","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":132,"numAtRisk":223},{"groupId":"EG001","numAffected":136,"numAtRisk":220},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAffected":10,"numAtRisk":14},{"groupId":"EG004","numAffected":3,"numAtRisk":4},{"groupId":"EG005","numAffected":1,"numAtRisk":3}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 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